annex vii medical devices

Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive. Where one or more of the samples fails to conform, the notified body must take the appropriate measures. Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the flow-rate can be set and maintained accurately enough to guarantee the safety of the patient and of the user. Medical Devices Directive (MDD) 93/42/EEC – Explained In the Medical Device Directive M.D.D. When appropriate, the necessary measures designed to amend nonessential elements of this Directive, relating to withdrawal from the market, prohibition of placing on the market and putting into service of a certain product or group of products or to restrictions or introduction of particular requirements in order for such products to be put on the market, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 7(3). 3. The notified body shall have documented procedures relating to renewals of EU technical documentation assessment certificates and EU type-examination certificates and those procedures shall require the manufacturer in question to submit a summary of changes and scientific findings for the device, including: The notified body shall have documented procedures to assess the information referred to in the second paragraph and shall pay particular attention to clinical data from post-market surveillance and PMCF activities undertaken since the previous certification or re-certification, including appropriate updates to manufacturers’ clinical evaluation reports. In addition, the notified body may pay unannounced visits to the manufacturer. Normally intended for continuous use for more than 30 days. For devices in Class IIb the notified body shall assess, as part of the assessment in Section 3.3, the technical documentation as described in Section 3.2(c) for at least one representative sample for each generic device group for compliance with the provisions of this Directive. It shall include in particular an adequate description of: 3.3. In the case of devices intended for clinical investigations, the manufacturer or the authorised representative, established in the Community, shall follow the procedure referred to in Annex VIII and notify the competent authorities of the Member States in which the investigations are to be conducted by means of the statement mentioned in Section 2.2 of Annex VIII. Annex 7 Form. the methods of monitoring the efficient operation of the quality system. 12.7.4. The notified body in question shall take full responsibility for the tasks performed by subcontractors. the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc. The notified body shall prior to making a final decision: The notified body shall have documented procedures for decision-making including as regards the allocation of responsibilities for the issuance, suspension, restriction and withdrawal of certificates. The scientific opinion of the competent national authority or the EMEA must be included in the documentation concerning the device. 2. Only medical devices of the lowest risk class do not need to involve a notified body in the conformity assessment procedure. all the relevant information on the product or product category covered by the procedure. Application of the classification rules shall be governed by the intended purpose of the devices. 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